Senior Clinical Study Manager

Key Responsibilities: 

• Proactively manage assigned clinical studies.

• Ensure overall clinical study efficiency and adherence to project timelines and budget; report metrics to Head Global Clinical Operations asrequired.

• Analyzeand manage clinical study risks, propose solutions for risk mitigation.

• Provide regular progress reports for clinical study activities through ongoing tracking and review of study project plans.

• Coordinate production of key clinical study documentation including Clinical Investigation Plan (CIP), Investigator Brochure (IB), Informed Consent Form (ICF)and Clinical Study Report (CSR).

• Motivate and manage a multi-disciplinary clinical study team.

• Handle escalations for study management questions and issues for assigned projects.

• Working closely with other functional groups withinConvatec’sClinical Operations team such as data management, clinical site management, qualityassuranceand biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.

• Manage 3rd party clinical monitoring Vendors where necessary to support milestone achievement and to manage study issues and obstacles.

• Build and develop relationships with key internal teams, including Medical Affairs and Medical Writing.

• Support audit and inspection activities as needed.

• Support adoption of best practices, updating processes and SOPs.

• Managing project budgets, tracking expenses, and ensuring projects stay withinallocatedfinancial resources.

• Responsible for managing the technical aspects, for all phases of the clinical study (development though study close-out) forConvatecclinical studies to ensure compliance with applicable SOPs, guidelines, and regulations.

• Responsible for managing risks, and monitoring progress to meet deadlines and stakeholder expectations.

• Leading and motivating project teams, providing direction and support, and fostering a collaborative environment. 

• Monitor and assess vendor performance against contractual operational deliverables.

• Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors.

• Manage study scope, quality, timelines, and budget with the internal functional leads, CRO and vendors to ensure projectobjectivesremain on track.

• Build solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities.

• Responsible for planning and conducting investigator meetings together with the CRO orConvatecmeeting event planner.

• Support the CRO and CRA to ensure patientenrollmentstrategies are conducted effectively and on time.

• Evaluate issues and implement solutions and mitigations asrequired.

• Createappropriate riskassessments and mitigation plans, perform regular reviews to continually assess changing circumstances.

• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical studyreportsand other documents and plans asappropriate.